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U.S. Department of Health and Human Services

Class 2 Device Recall OneTray Sealed Sterilization Container

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  Class 2 Device Recall OneTray Sealed Sterilization Container see related information
Date Initiated by Firm February 03, 2014
Date Posted October 22, 2015
Recall Status1 Terminated 3 on February 04, 2016
Recall Number Z-0153-2016
Recall Event ID 72011
510(K)Number K052567  
Product Classification Sterilization wrap containers, trays, cassettes & other accessories - Product Code KCT
Product OneTray Sealed Sterilization Containers

Product Usage:
A rigid sterilization container used to steam sterilize medical devices
Code Information M2104 Lot # 044305, 044379, 044380 & 044418.  M2408 Lot # 044296, 022304, 044381, 044420, 044421 & 044422.
Recalling Firm/
Innovative Sterlization Technologies LLC
7625 Paragon Rd Ste A
Dayton OH 45459-4063
For Additional Information Contact Mr. David S. Billman
Manufacturer Reason
for Recall
The wrong sterilization time was on the label. The label lists Steam Gravity 10 - 34 minutes at 270 degrees F instead of Steam Gravity 17 - 34 minutes at 270 degrees F.
FDA Determined
Cause 2
Process control
Action The firm sent an Urgent Medical Device Recall letter dated September 14, 2015 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to fill out the attached response SASE mailer and return to or fax to the address/number identified below: Innovative Sterilization Technologies, LLC, 7625 Paragon Road, Suite A Dayton, OH 45459, 937-286-3571 (C), 937-630-4346 (F), 937-619-0138 x 202 (Office), dbillman@ISTSterilization.com
Quantity in Commerce M2104 - 25 units; M2408 - 84 units
Distribution US Nationwide Distribution in the states of IL, IN, LA, OH, PA, TX & WV.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KCT and Original Applicant = STERILE CONTAINMENT TECHNOLOGY, LLC.